atovaquone

FDA Drug Profile — MEPRON, atovaquone

atovaquone is listed in the FDA National Drug Code directory with 6 NDC codes, marketed under brand names including MEPRON, atovaquone. Available dosage forms: suspension, powder.

Drug Details

Generic Name
atovaquone
Brand Names
MEPRON, atovaquone
Application Number
NDA020500
Sponsor
GlaxoSmithKline LLC
NDC Codes
6
Dosage Forms
SUSPENSION, POWDER
Routes
ORAL
Active Ingredients
ATOVAQUONE

Indications and Usage

1 INDICATIONS AND USAGE Atovaquone and proguanil hydrochloride tablets are an antimalarial indicated for: • prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. ( 1.1 ) • treatment of acute, uncomplicated P. falciparum malaria. ( 1.2 ) 1.1 Prevention of Malaria Atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. 1.2 Treatment of Malaria Atovaquone and proguanil hydrochloride tablets are indicated for the treatment of acute, uncomplicated P. falciparum malaria. Atovaquone and proguanil hydrochloride tablets have been shown to be effective in regions where the drugs chloroquine, halofantrine, mefloquine, and amodiaquine may have unacceptable failure rates, presumably due to drug resistance.